Components of DTaP Vaccine	Excipients Table Allergens Table Components Table
Indication To prevent infection with Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis Proprietary Name Daptacel Infanrix Kinrix Tripedia Manufacturer sanofi pasteur GlaxoSmithKline GlaxoSmithKline sanofi pasteur Viability Inactivated bacterial vaccine Inactivated bacterial vaccine Inactivated bacterial vaccine Inactivated bacterial vaccine Microorganism Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani Dose 0.5 mL 0.5 mL 0.5 mL 0.5 mL Route Intramuscular Intramuscular Intramuscular Intramuscular Dose form Suspension Suspension   Suspension Appearance White homogeneous cloudy suspension after shaking Turbid white suspension after shaking Homogeneous, turbid white suspension Homogenous white suspension after shaking Concentration (per 0.5  mL)   Diphtheria, 15 Lf u Tetanus, 5 Lf u PT, 10mcg FHA, 5mcg Pertactin, 3mcg Fimbriae types 2 and 3, 5 mcg Diphtheria, 25 Lf u Tetanus, 10 Lf u Pertussis: PT, 25 mcg; FHA, 25 mcg; Pertactin, 8 mcg  Diphtheria, 25 Lf u Tetanus toxoid, 10 Lf Pertussis toxin, 25 mcg FHA, 25 mcg Pertactin, 8 mcg Type 1 poliovirus, 40 DU Type 3 poliovirus, 32 DU Diphtheria, 6.7 Lf u Tetanus, 5 Lf u Pertussis toxin (PT), 23.4 mcg; Filamentous Hemaglutinin (FHA), 23 mcg Preservatives/dose 2-Phenoxyethanol, 3.3 mg (0.6% v/v) 2-Phenoxyethanol, 2.5 mg None Thimerosal, ≤0.3 mcg Adjuvant Aluminum Phosphate, 0.33 mg Aluminum Hydroxide, ≤0.625 mg Aluminum, 4.5 mg Aluminum potassium sulfate, ≤0.17 mg Excipients Formaldehyde, ≤0.1 mg Glutaraldehyde, ≤50 ng Formaldehyde, ≤100 mcg Polysorbate 80, ≤ 100 mcg Sodium chloride, 4.5 mg/mL   Formaldehyde, ≤100 mcg Polysorbate 80, ≤ 100 mcg Sodium chloride, 4.5 mg Formaldehyde, ≤100 mcg Gelatin Polysorbate 80 Allergens Stopper vial may contain dry natural latex rubber Stopper vial may contain dry natural latex rubber Neomycin, ≤0.05 ng Polymyxin , ≤0.01 ng Tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber Vial stopper is latex-free Stopper vial may contain dry natural latex rubber Media         Bordetella pertussis Stainer-Scholte medium Modified by Casamino Acids and Dimethyl-beta-cyclodextrin Modified Stainer-Scholte liquid medium Modified Stainer-Scholte liquid medium Stainer-Scholte modified by casamino acids and dimethyl-beta-cyclodextrin Corynebacterium diphtheria Modified Mueller’s growth medium Purified using  Ammonium Sulfate Fractionation. Detoxified using Formalin Fenton medium containing bovine extract Detoxified using Formaldehyde PT detoxified using Glutaraldehyde FHA and Pertactin detoxified using formaldehyde Fenton medium containing bovine extract Modified Mueller’s growth medium Detoxified using formaldehyde Purified using serial ammonium sulfate fractionation and diafiltration Clostridium tetani Mueller-Miller Casamino acid medium Detoxified using formalin Purified by Ammonium Sulfate fractionation Modified Lantham medium derived from bovine casein Detoxified using formaldehyde Modified Lantham medium derived from bovine casein Peptone-based medium containing a bovine extract Detoxified using formaldehyde Purified using serial ammonium sulfate fractionation and diafiltration Packaging 0.5 mL vials 0.5 mL vials and disposable prefilled syringes 0.5 mL vials and disposable prefilled syringes 0.5 mL vials Routine Storage 2 to 8° C (35-46° F) Do not freeze 2 to 8° C (36-46° F) Do not freeze 2 to 8° C (36-46° F) Do not freeze 2 to 8° C (35-46° F) Do not freeze updated May 2010
This page was last updated on May 28, 2010 © 2010 Institute for Vaccine Safety